Trial of Exenatide for Parkinson's Disease

NCT01971242 | Completed Phase 2 DMC

• 1 other identifier: 2013-003363-64
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a clinical trial in patients with Parkinson's disease, of a drug called Exenatide which is already licensed for the treatment of patients with Type 2 Diabetes. There have been several groups that have confirmed that Exenatide has beneficial effects on nerve cells when tested in the laboratory, that raises the possibility that Exenatide may slow down or stop the degenerative process of Parkinson's disease. In an open label trial in patients with Parkinson's disease who self administered the drug for 1 year, we have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease, even 2 months after patients stopped administering the drug. The next step is therefore to formally evaluate whether Exenatide really is a potential "neuroprotective" drug, i.e. stops the nerve cells dying in Parkinson's disease, by conducting a double blind, placebo controlled trial.

Conditions

Parkinson's Disease

Keywords

Parkinson's; Parkinson's Disease; Exenatide; Bydureon

Outcome Measures

Primary Outcomes (1)

• Efficacy

  The primary objective is to compare the effectiveness of Exenatide versus placebo on the MDS UPDRS part 3 motor subscale in the "practically defined OFF medication state" in patients with moderate severity PD.

  60 weeks

Secondary Outcomes (1)

• Safety and tolerability

  60 weeks

Other Outcomes (1)

• Exploratory outcomes

  Compare differences at 48 and 60 weeks

Study Arms (2)

Exenatide

ACTIVE COMPARATOR

Bydureon- 2mg administered subcutaneously once weekly

Drug: Exenatide

Placebo

PLACEBO COMPARATOR

Placebo, 2mg administered subcutaneously once weekly

Other: Placebo

Interventions

Exenatide DRUG

2mg, SC (subcutaneous) once weekly. Number of weeks: 48 weeks. Exenatide is a 39-amino-acid peptide

Also known as: Bydureon

Exenatide

Placebo OTHER

Placebo, 2mg, SC (subcutaneous), once weekly for 48 weeks.

Placebo

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease.
• Males or Females.
• Hoehn and Yahr stage ≤ 2.5 in the On medication state.
• Between 25 and 75 years of age.
• On dopaminergic treatment with wearing off phenomena.
• Ability to self-administer, or to arrange carer administration of trial drug.
• Documented informed consent to participate.

You may not qualify if:

• Diagnosis or suspicion of other cause for parkinsonism.
• Body mass index \<18.5.
• Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/DaTSCAN acquisition.
• Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale.
• Concurrent severe depression defined by a score \>16 on the MADRS.
• Prior intra-cerebral surgical intervention for Parkinson's disease.
• Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease.
• Severe gastrointestinal disease (e.g. gastroparesis).
• Previous exposure to Exenatide.
• Severely impaired renal function with creatinine clearance \<30ml/min.
• History of pancreatitis.
• Hyperlipidaemia.
• History or suspicion of thyroid cancer
• Known or suspected intolerance of DaTSCAN or Potassium Iodide administration.
• Females that are pregnant or breast feeding.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

National Hospital for Neurology & Neurosurgery (part of UCLH NHS Trust)

London, WC1N 3BG, United Kingdom

Location

Related Publications (1)

• Athauda D, Maclagan K, Skene SS, Bajwa-Joseph M, Letchford D, Chowdhury K, Hibbert S, Budnik N, Zampedri L, Dickson J, Li Y, Aviles-Olmos I, Warner TT, Limousin P, Lees AJ, Greig NH, Tebbs S, Foltynie T. Exenatide once weekly versus placebo in Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet. 2017 Oct 7;390(10103):1664-1675. doi: 10.1016/S0140-6736(17)31585-4. Epub 2017 Aug 3.

  PMID: 28781108 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Thomas Foltynie, Dr

  UCL Institute of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: June 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 17, 2016

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)